文章：

来那度胺联合地塞米松治疗后早期行自体干细胞移植的新诊断多发性骨髓瘤患者结局：ECOG-ACRIN E4A03随机临床试验的长期随访

Outcome with lenalidomide plus dexamethasone followed by early autologous stem cell transplantation in patients with newly diagnosed multiple myeloma on the ECOG-ACRIN E4A03 randomized clinical trial: long-term follow-up

原文发布日期：2016-09-02

DOI: 10.1038/bcj.2016.68

类型: Original Article

开放获取: 是

英文摘要：

In Eastern Cooperative Oncology Group-ACRIN E4A03, on completion of four cycles of therapy, newly diagnosed multiple myeloma patients had the option of proceeding to autologous peripheral blood stem cell transplant (ASCT) or continuing on their assigned therapy lenalidomide plus low-dose dexamethasone (Ld) or lenalidomide plus high-dose dexamethasone (LD). This landmark analysis compared the outcome of 431 patients surviving their first four cycles of therapy pursuing early ASCT to those continuing on their assigned therapy. Survival distributions were estimated using the Kaplan–Meier method and compared with log-rank test. Ninety patients (21%) opted for early ASCT. The 1-, 2-, 3-, 4- and 5-year survival probability estimates were higher for early ASCT versus no early ASCT at 99, 93, 91, 85 and 80% versus 94, 84, 75, 65 and 57%, respectively. The median overall survival (OS) in the early versus no early ASCT group was not reached (NR) versus 5.78 years. In patients <65 years of age, median OS in the early versus no early ASCT groups was NR in both, hazard ratio 0.79, 95% confidence interval: (0.50, 0.25). In patients ⩾65 years of age, median OS in the early versus no early ASCT was NR versus 5.11 years. ASCT dropped out of statistical significance (P=0.080). Patients opting for ASCT after induction Ld/LD had a higher survival probability and improvement in OS regardless of dexamethasone dose density.

摘要翻译： 

在东部肿瘤协作组-ACRIN E4A03研究中，完成四个周期治疗后，新诊断多发性骨髓瘤患者可选择进行自体外周血干细胞移植（ASCT）或继续接受原定治疗方案（来那度胺联合小剂量地塞米松[Ld]或来那度胺联合大剂量地塞米松[LD]）。本界标分析将431例在初始四个周期治疗中存活的患者分为早期ASCT组与继续原定治疗组进行结局比较。采用Kaplan-Meier法评估生存分布，并行对数秩检验。90例患者（21%）选择早期ASCT。早期ASCT组与未早期ASCT组的1年、2年、3年、4年及5年生存概率估计值分别为99%、93%、91%、85%、80% 对比 94%、84%、75%、65%、57%。早期ASCT组与未早期ASCT组的中位总生存期（OS）分别为未达到（NR）与5.78年。在65岁以下患者中，早期ASCT组与未早期ASCT组的中位OS均未达到，风险比0.79（95%置信区间：0.50-0.25）。在65岁及以上患者中，早期ASCT组与未早期ASCT组的中位OS分别为未达到与5.11年，但ASCT未达到统计学显著性（P=0.080）。无论地塞米松剂量强度如何，诱导治疗Ld/LD后选择ASCT的患者均表现出更高的生存概率和总生存期改善。

原文链接：

Outcome with lenalidomide plus dexamethasone followed by early autologous stem cell transplantation in patients with newly diagnosed multiple myeloma on the ECOG-ACRIN E4A03 randomized clinical trial: long-term follow-up